EEG Spectrogram, Brain Vulnerability and POD

Sponsor
University of Nottingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05368272
Collaborator
(none)
30
1
4
7.5

Study Details

Study Description

Brief Summary

An assessment of difference in prespecified processed electroencephalography variables between cognitively intact older surgical patients who develop postoperative delirium compared to those who do not develop postoperative delirium

Condition or Disease Intervention/Treatment Phase
  • Other: Processed electroencephalography
  • Other: Postoperative delirium assessment

Detailed Description

Postoperative delirium in older people may be contributed to by intrinsic brain vulnerability such as pre-existing dementia. Some cognitively intact older people also experience postoperative delirium and in these patients some go on to develop later dementia. The investigators propose that postoperative delirium may be an unmasking of covert brain vulnerability by the dyshomeostasis of the anaesthesia/surgical intervention.

In people with dementia or mild cognitive impairment, electroencephalography (EEG) studies have shown slowing of brain wave activity, especially in the back of the brain.

Processed electroencephalography, using a limited number of channels, is routinely used during anaesthesia to aid assessment of anaesthetic depth of the patient.

In this study the investigators will assess the feasibility of acquiring EEG data from the front and back of the brain. The investigators will also explore the data for early signals of brain vulnerability

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
EEG Spectrogram to Assess Brain Vulnerability as a Risk Factor for Postoperative Delirium in Older People - a Feasibility Study
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Feasibility of acquiring frontal and posterior EEG data from the Narcotrend monitor during the preoperative and intraoperative period [Approximately 1 - 2 hours per participant]

    Feasibility will be assessed by the ability to get preoperative and intraoperative epochs of EEG that clearly demonstrates the different brain wave bands (alpha, theta and delta)

Secondary Outcome Measures

  1. Preoperative brain wave differences [Approximately 10 minutes per participant]

    Identify any differences in frontal and posterior narrowband (i.e. alpha, delta and theta) power preoperatively between older people who develop POD compared to those who do not.

  2. Change in brain wave power due to induction of anaesthesia [Approximately 1 hour per particpant]

    Identify if the change in narrowband power from the preoperative values to steady state intraoperative values are different between groups (i.e. people who develop POD vs people who do not develop POD)

  3. Intraoperative brain wave patterns [Duration of surgery or 2 hours (shortest option)]

    Identify any differences in mean and spectral edge frequencies preoperatively and intraoperatively between older people who develop POD and those who do not.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ≥ 65 years old

  • Elective, moderate/major, non-neuro, non-cardiac surgery

  • Ability to give informed consent

Exclusion Criteria:
  • Preoperative cognitive impairment

  • Current systemic infection

  • Current use of medication that may modify EEG

  • History of neurosurgery/significant head trauma

  • Presence of neurological diseases including overt stroke, dementia, epilepsy, multiple sclerosis, Parkinson's disease, intracranial tumours and other significant neurologic disorders

  • Current significant psychiatric conditions such as severe depression.

  • Palliative surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen's Medical Centre Nottingham United Kingdom

Sponsors and Collaborators

  • University of Nottingham

Investigators

  • Principal Investigator: Iain Moppett, FRCA, MD, University of Nottingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Nottingham
ClinicalTrials.gov Identifier:
NCT05368272
Other Study ID Numbers:
  • 21074
First Posted:
May 10, 2022
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Nottingham
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022